Tolerx and GlaxoSmithKline Announce Phase 3 Defend-1 Study of Otelixizumab in Type 1 Diabetes Did Not Meet Its Primary Endpoint

CAMBRIDGE, Mass. and LONDON, March 11, 2011 /PRNewswire/ --
Tolerx, Inc. and GlaxoSmithKline (GSK) today announced that
the Phase 3 DEFEND-1 study of otelixizumab, an investigational
humanized anti-CD3 monoclonal antibody, did not meet the primary
efficacy endpoint of change in C-peptide at month 12 in patients
with new-onset autoimmune type 1 diabetes.

Following preliminary review of the data, no new or unexpected
treatment-related safety concerns have emerged during the DEFEND-1
study. Study investigators and regulatory agencies have been
notified of the DEFEND-1 study outcome.

GSK will continue to explore additional dosing regimens to
inform decisions about the future clinical development programme
for otelixizumab. New recruitment and dosing in the DEFEND-2
study, the ongoing confirmatory Phase 3 study with a design similar
to DEFEND-1, has been suspended pending review of the DEFEND-1
results.

"While we are disappointed in the DEFEND-1 results of
otelixizumab, we remain committed to the development and
commercialization of the candidates in our pipeline, each of which
has a distinct mechanism and target for correcting abnormal immune
responses," said Douglas J. Ringler, VMD, President and Chief
Executive Officer of Tolerx. "Our immunotherapy candidates
represent some of the latest scientific advances in harnessing the
immune system for therapeutic benefit, including TRX518 which is a
showpiece of our pipeline as an immunotherapy to treat cancer."

"Clearly these are disappointing data, but we are committed to
working with Tolerx to better understand the results of this study
and determine the way forward," said Jackie Parkin, Medicines
Development Leader, GlaxoSmithKline.

Tolerx Pipeline

In addition to otelixizumab, Tolerx has four product candidates
in various stages of development, and each candidate is based on
Tolerx's immunology expertise in understanding how therapies can be
designed